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MADRID, July 30 (EUROPE PRESS) –
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of ranibizumab, registered by Novartis under the name "Lucentis", the treatment of premature children with retinopathy premature (ROP), a rare eye disease that is one of the leading causes of childhood blindness.
"Given this population of vulnerable patients and the limitations of current treatments, randomized controlled clinical trials are important to ensure the safe and effective use of drug treatments in pediatric patients." "It is approved, the Ranibizumab will be an attractive option for alternative treatment to laser therapy, "said Andreas Stahl, Director of the Department of Ophthalmology at Greifswald University Medical Center (Germany).
The European Commission will review the opinion of the CHMP and should make its final decision within three months. If approved for this indication, "Lucentis" will be the first and only pharmacological treatment indicated for ROP in this population of vulnerable patients.
The application is based on the Randomized Controlled Clinical Trial "Rainbow", which showed that "Lucentis" was used in the study. is effective, safe and well tolerated in children with ROP. If approved in the European Union, "Lucentis" (dose of 0.2 mg) will be indicated for the treatment of premature newborns with a disease in Zone I, Zone II or ROP- PA (subsequent aggressive ROP).
"We recognize the importance of investing in clinical programs to ensure market authorization and safe use of drug therapies in vulnerable pediatric patient populations. We are very happy to be able to offer this transformative treatment to premature patients. The favorable opinion of the CHMP demonstrates our unwavering commitment to innovation, which addresses unmet needs and reinvents eye care in all age groups, "said Head of Development Unit, Novartis Ophthalmology, Dirk Sauer.
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